AIDS Groups Have Roche Patent In India Set Aside
4 CommentsBy Ed Silverman // December 10th, 2008 // 7:20 am
In a first-ever instance of a patent being revoked after being granted, India’s High Court has set aside pharma major Roche’s patent on a key drug on procedural grounds, The Times of India reports.
Valganciclovir, also known as Valcyte, treats cytomegalovirus (CMV), a virus that attacks the retina of people with lower immune systems, such as AIDS patients. In addition, it is crucial for prevention of CMV infection in patients who have received organ transplant. Roche was granted a patent in June 2007.
The court has cited the failure of the Indian patent office to comply with patent law and sent the case back to the Patent Controller. The judgment was delivered on a petition filed by two activist groups, Indian Network for People Living with HIV/AIDS and Tamil Nadu Networking People with HIV/AIDS, which challenged the decision to grant a patent without hearing opposition filings.
In July 2006, the groups filed papers objecting to granting a patent to Roche and requested for a hearing. Under Indian law, if an opponent requests a hearing, the patent office is required to provide the opponent an opportunity to be heard, but this never happened. Meanwhile, Roche charged an unaffordable price for the tablet and its patent prevented lower-cost generics from entering the market, although Cipla launched a copycat anyway, prompting a lawsuit from Roche.
The dispute between the companies hinges on “patentability” of the drug. The validity of the patent is in question under the country’s patent laws that do not allow patents on new forms of old drugs. The generic producers of the drug, Matrix, Ranbaxy and Cipla have also filed post grant oppositions.
While the opportunity to oppose the application is only granted to the patient groups, it is likely that Roche’s injunction proceedings against Cipla for launching the generic version will no longer have a legal basis as the patent is now revoked. Whether the Mumbai court will keep the infringement proceedings pending remains to be seen, legal experts say.
Shamnad Basheer
Dear Ed,
Very lucid writing, as always. While the body of the article appears correct (in terms of legal posn), the title may be misleading. “Revocation” is a term that usually connotes the cancellation of a granted patent once and for all. In this case, the court has merely only set aside the initial grant (owing to a procedural irregularity) and asked the patent office to hear the “opposing” party and consider the application in the light of this hearing. In other words, if the patent office, even after hearing, concludes that the patent ought to be granted, it may do so. Contrast this with a traditional understanding of “revocation”, under which the patent is struck off once and for all.
RSK
I don’t think this is a revocation.
The Court has order the patent to be held in abeyance pending a fresh hearing on the Pre-grant opposition.
Should you need more info. or want to dicuss, you have my email [above].
RSK
Fresh info:
Roche today has scored a small victory against Cipla in the Valganciclovir patent + TM saga.
Mumbai High Court has given an injunction to Roche against Cipla for the use of a mark similar to Roche’s mark [Valcyte].
NOTE: This order does not have any connection with the afore mentioned patent matter. The Chennai HC had already [temporarily] suspended the Valganciclovir patent.
In India, in the past, Lilly had won against Ajanta Pharma on a similar case. Ajanta had used a mark [probably 'Ceealis'] very similar to Lilly’s Cialis for Tadalafil. The Court ordered Ajanta to change the name, but no stock recall was ordered then.
Ed Silverman
Hi Shamnad and RSK,
A very belated thanks for pointing out the need to clarify the headline. I apologize for not responding sooner, but was out of the ‘office’ much of the day and didn’t see your comments until hours later. However, I have changed the headline and appreciate that you both took the time to write me.
All best,
ed